New Study Results Demonstrate Clinical Effectiveness of Gemzar(R)-Based Combination Therapy for Advanced Breast Cancer
May 16 2005 - 1:15PM
PR Newswire (US)
New Study Results Demonstrate Clinical Effectiveness of
Gemzar(R)-Based Combination Therapy for Advanced Breast Cancer
INDIANAPOLIS, May 16 /PRNewswire-FirstCall/ -- New data from a
Phase III clinical trial(1) show that Eli Lilly and Company's (LLY)
Gemzar(R) (gemcitabine, HCl) in combination with Taxotere(R)
(docetaxel) demonstrated similar efficacy, but with an improved
safety profile, when compared to a regimen of Xeloda(R)
(capecitabine) and docetaxel in the treatment of metastatic breast
cancer. The study, presented today at the 41st annual meeting of
the American Society of Clinical Oncology (ASCO), compared the two
combinations as first- or second-line treatment in patients with
metastatic breast cancer. The study further demonstrates Gemzar's
ability to be combined with other agents in providing patients with
the benefit of survival, while maintaining a manageable level of
side effects. Gemzar in combination with Taxol(R) (paclitaxel) is
approved for use in the U.S., Europe and more than 60 countries for
the treatment of metastatic breast cancer. Patients receiving the
Gemzar-based combination had the same progression- free survival
time (the length of time during and after treatment that the cancer
does not grow) and tumor response rate (tumor shrinkage) as
patients receiving the capecitabine-based combination. Patients
administered the Gemzar combination also experienced significantly
fewer toxic side effects, such as mucositis (an inflammation of the
gastrointestinal lining resulting in painful sores in the mouth and
throat), diarrhea and hand-foot syndrome (a drug-related skin
condition that results in redness, tenderness, peeling and numbness
of the palms and soles). "Treatment-related side effects can be
severely debilitating for women with metastatic breast cancer and
have a tremendous impact on their quality of life," said Stephen
Chan, M.D., Consultant Oncologist, Nottingham City Hospital, United
Kingdom, and primary investigator of the study. "The combination of
efficacy and improved tolerability seen in this study with
Gemzar/docetaxel suggests that we've taken an important step
forward where we can treat the cancer while helping women live
their everyday lives more comfortably and with less risk of side
effects." Study Highlights This 16-month study evaluated 302
patients with pre-treated metastatic breast cancer who were
randomized and treated with either Gemzar/docetaxel (n=152) or
capecitabine/docetaxel (n=150) combination therapy. The primary
endpoint of this study was progression-free survival. Secondary
endpoints were overall response rate, time to treatment failure,
overall survival, toxicity and quality of life. Patients in the
Gemzar/docetaxel arm were treated with 1000 mg/m2 of Gemzar
combined with 75 mg/m2 of docetaxel, and patients in the
capecitabine/docetaxel arm were treated with 1250 mg/m2 of
capecitabine combined with 75 mg/m2 of docetaxel. Patients in the
Gemzar/docetaxel group and capecitabine/docetaxel group received
875 and 758 cycles of therapy, respectively. * Patients receiving
Gemzar/docetaxel had the same median progression- free survival
time and overall tumor response rate as patients who received
capecitabine/docetaxel * The Gemzar/docetaxel combination resulted
in fewer non-hematologic toxic side effects compared to
capecitabine/docetaxel -- Grade 3/4 mucositis - 4 percent vs. 17
percent -- Grade 3/4 diarrhea - 8 percent vs. 18 percent -- Grade
3/4 hand-foot syndrome - 0 percent vs. 26 percent *
Gemzar/docetaxel resulted in a slightly higher percentage of
hematologic side effects compared to capecitabine/docetaxel with
the exception of febrile neutropenia (a fever accompanied by a
significant reduction in white blood cell count, leading to greater
likelihood of developing an infection and increased need for
hospitalization) -- Grade 3/4 neutropenia (a lowering of the white
blood cell count that can cause infections and fever, thus
requiring hospitalization) - 85 percent vs. 82 percent -- Grade 3/4
leukopenia (an abnormal decrease in the number of white blood
cells) - 80 percent vs. 66 percent -- Grade 3/4 thrombocytopenia (a
decrease in the number of platelets in the blood, resulting in the
potential for increased bleeding and decreased ability for
clotting) - 10 percent vs. 3 percent -- Grade 3/4 febrile
neutropenia - 8 percent vs. 13 percent -- Grade 3/4 anemia (a
decrease in red blood cell count resulting in insufficient oxygen
to tissues and organs) - 7 percent vs. 3 percent * There was a
lower discontinuation rate due to adverse events in the
Gemzar/docetaxel group compared to the capecitabine/docetaxel group
(13 percent vs. 28 percent, respectively) - more patients stopped
their therapy on the capecitabine/docetaxel arm due to a higher
occurrence of adverse events. * There were two toxic deaths in the
trial, both occurring in the capecitabine/docetaxel group of
patients. According to the World Health Organization, more than one
million people worldwide will be diagnosed with breast cancer this
year, making it the most common cancer among women(2). "Gemzar has
been shown to have significant therapeutic value on its own as a
cancer-fighter and as a highly combinable agent. We are extremely
pleased that Gemzar-based combination therapy continues to deliver
in the fight against breast cancer," said Allen Melemed, M.D.,
medical advisor, Eli Lilly and Company. "Women and their physicians
deserve our total and ceaseless commitment to finding new options
in breast cancer, and we will continue to look for ways to improve
the treatment picture." Gemzar Gemzar is one of the most widely
studied treatments in the history of chemotherapy agents, and has
been approved for use in more than 90 countries worldwide. It is
the worldwide standard for care of pancreatic cancer and in many
parts of the world for non-small cell lung, bladder and breast
cancers. Gemzar is approved in more than 75 countries as a single
agent for the treatment of locally advanced or metastatic
pancreatic cancer. It is also approved, in combination with
Taxol(R) (paclitaxel), in more than 60 countries for the treatment
of metastatic breast cancer. In most European countries, Gemzar is
approved as a single agent or in combination with cisplatin for the
treatment of advanced non-small cell lung cancer. Gemzar, in
combination with carboplatin, is approved in several European
markets for the treatment of recurrent epithelial ovarian cancer.
Most recently, Gemzar was approved in Mexico for cervical cancer,
making it the first approval for this disease. Gemzar is a
nucleoside analogue that interferes with the process of DNA
production; thereby preventing cancer cells from replicating and
thus slows or stops tumor growth. Eli Lilly and Company Lilly, a
leading innovation-driven corporation, is developing a growing
portfolio of first-in-class and best-in-class pharmaceutical
products by applying the latest research from its own worldwide
laboratories and from collaborations with eminent scientific
organizations. Headquartered in Indianapolis, Indiana, Lilly
provides answers -- through medicines and information -- for some
of the world's most urgent medical needs. Additional information
about Lilly is available at http://www.lilly.com/. P-LLY This press
release contains forward-looking statements about Gemzar in
combination with Taxotere and reflects Lilly's current beliefs.
However, as with any pharmaceutical product under development,
there are substantial risks and uncertainties in the process of
development and commercialization. There is no guarantee that the
product will receive additional regulatory approvals and there is
also no guarantee that the product will continue to be commercially
successful. For further discussion of these and other risks and
uncertainties, see Lilly's filing with the United States Securities
and Exchange Commission. Lilly undertakes no duty to update
forward-looking statements. Gemzar(R) (gemcitabine HCl, Lilly)
Taxol(R) (paclitaxel, Bristol-Myers Squibb) Xeloda(R)
(capecitabine, Roche) Taxotere(R) (docetaxel, Sanofi-Aventis) (1)
Gemcitabine plus docetaxel versus capecitabine plus docetaxel for
anthracycline-pretreated metastatic breast cancer patients: Results
of a European phase III study; Chan S, Romieu G, Huober J, Delozier
T, Tubiana- Hulin M, Lluch A, Schneeweiss A, Llombart A, Carrasco
E, Fumoleau P (2) "Global cancer rates could increase by 50% to 15
million by 2020." World Health Organization 3 April 2003; Accessed
26 April 2005
http://www.who.int/mediacentre/news/releases/2003/pr27/en/
Gemzar/docetaxel Xeloda/docetaxel (n=152) (n=150) Median
Progression-Free Survival Time 35 weeks 35 weeks Overall Tumor
Response Rate 32 percent 32 percent Grade 3/4 Mucositis 4 percent
17 percent Grade 3/4 Diarrhea 8 percent 18 percent Grade 3/4
Hand-Foot Syndrome 0 percent 26 percent Grade 3/4 Neutropenia 85
percent 82 percent Grade 3/4 Leukopenia 80 percent 66 percent Grade
3/4 Thrombocytopenia 10 percent 3 percent Grade 3/4 Febrile
Neutropenia 8 percent 13 percent Grade 3/4 Anemia 7 percent 3
percent Serious adverse events 30 percent 38 percent
Discontinuation rate due to adverse events 13 percent 28 percent
(Logo: http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO )
http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO DATASOURCE:
Eli Lilly and Company CONTACT: Gregory L. Clarke (U.S. Media),
+1-317-276-5222 (phone), +1-877-892-7864 (pager), or Carla L. Cox
(Non-U.S. Media), +1-317-651-1473 (phone), +1-888-446-5740 (pager),
both of Eli Lilly and Company
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